FDA.report

Ortho Performance®

Primary DI
10190707143036
Brand
Ortho Performance®
Company
Ortho Organizers, Inc.
Model
600-005
Device description
ORTHO PERFORMANCE Z02 Relief Wax Mint 50/pk
Published
2025-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707143039PrimaryGS10
10190707143036Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707143039001907071430391907071430390190707143039
1019070714303610190707143036

GMDN Terms

TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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